SynthesisEBioMedicine2022
Accelerating model-informed decisions for COVID-19 vaccine candidates using a model-based meta-analysis approach.
Synthesis in EBioMedicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
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Who cites it
4 citing papers in PubMed.
- Model-Informed Drug Development Applications and Opportunities in mRNA-LNP Therapeutics.Clinical pharmacology and therapeutics · 2025Review
- Efficacy of monoclonal antibodies and maternal vaccination for prophylaxis of respiratory syncytial virus disease.Communications medicine · 2025Article
- Improving precision of vaccine efficacy evaluation using immune correlate data in time-to-event models.NPJ vaccines · 2024Article
- Dynamical modelling of viral infection and cooperative immune protection in COVID-19 patients.PLoS computational biology · 2023Article
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Authors and funding
12 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe COVID-19 pandemic has increased the need for innovative quantitative decision tools to support rapid development of safe and efficacious vaccines against SARS-CoV-2. To meet that need, we developed and applied a model-based meta-analysis (MBMA) approach integrating non-clinical and clinical immunogenicity and protection data.
methodsA systematic literature review identified studies of vaccines against SARS-CoV-2 in rhesus macaques (RM) and humans. Summary-level data of 13 RM and 8 clinical trials were used in the analysis. A RM MBMA model was developed to quantify the relationship between serum neutralizing (SN) titres after vaccination and peak viral load (VL) post-challenge in RM. The translation of the RM MBMA model to a clinical protection model was then carried out to predict clinical efficacies based on RM data alone. Subsequently, clinical SN and efficacy data were integrated to develop three predictive models of efficacy - a calibrated RM MBMA, a joint (RM-Clinical) MBMA, and the clinical MBMA model. The three models were leveraged to predict efficacies of vaccine candidates not included in the model and efficacies against newer strains of SARS-CoV-2.
findingsClinical efficacies predicted based on RM data alone were in reasonable agreement with the reported data. The SN titre predicted to provide 50% efficacy was estimated to be about 21% of the mean human convalescent titre level, and that value was consistent across the three models. Clinical efficacies predicted from the MBMA models agreed with reported efficacies for two vaccine candidates (BBV152 and CoronaVac) not included in the modelling and for efficacies against delta variant.
interpretationThe three MBMA models are predictive of protection against SARS-CoV-2 and provide a translational framework to enable early Go/No-Go and study design decisions using non-clinical and/or limited clinical immunogenicity data in the development of novel SARS-CoV-2 vaccines.
fundingThis study was funded by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
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